Chronicle
Proprietary Statandocs software for technical assembly of electronic registration dossiers, submission lifecycle management and preparation of files for regulatory submission.
Electronic dossier assembly and lifecycle management
Dossier structure and documents
Organise source materials within the dossier structure and prepare the package for technical assembly.
Sequences and submission history
Work with initial submissions, variations, renewals and responses to questions across the dossier lifecycle.
Submission-ready output
Generate XML or an archive according to the applicable requirements and selected module.
EAEU and a separate WHO module
The main focus is EAEU electronic dossiers. A separate module supports WHO prequalification tasks.
Use and support
Use the software or commission assembly of a specific sequence. Dossier content preparation and submission support are also available as separate Statandocs services.
Discuss accessChronicle product information and documentation
A separate page provides information about Chronicle (1C:eCTD), its user manual, architecture, support processes and functional characteristics. The documents are in Russian.
Open the Chronicle documentation page